Purpose To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). Design An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Participants Patients aged ≥18 years with high myopia (≥-6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Methods Patients were randomized 3:1 to intravitreal aflibercept or sham. In the intravitreal aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Main Outcome Measures Mean change in BCVA from baseline to week 24. Results A total of 122 patients were randomized to intravitreal aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters, respectively (P < 0.0001). By week 48, patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters. Patients in the intravitreal aflibercept group received 2 injections (median) in the first study quarter (week 0-8). Median number of injections in quarters 2 to 4 was 0. Patients in the "sham/intravitreal aflibercept" group received 2 and 1 (median) intravitreal aflibercept injections in quarters 3 and 4. Central retinal thickness improved in parallel with visual gains. Incidence of ocular adverse events was similar in both groups through week 48 (37.4% vs. 38.7); most were assessed by investigators as mild. No deaths occurred. Conclusions Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal aflibercept should be considered as a treatment option for myopic CNV.
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